Safety and Efficacy of Insulin Aspart in Children With Type 1 Diabetes

Diabetes Clinical Trial

Official title:

Meal-related Insulin Aspart Therapy Versus Meal-related Human Insulin Therapy in Children 2-6 Years of Age With Type 1 Diabetes Mellitus: A Multi-centre Randomised, Open-labelled, Cross-over, Safety and Efficacy Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01467141
• Other study ID #: ANA-1415
• Status: Completed
• Phase: Phase 4
• First received: November 4, 2011
• Last updated: February 22, 2017
• Start date: June 19, 2002
• Est. completion date: October 15, 2003

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial is conducted in Europe. The aim of this trial is to evaluate safety and efficacy in children with type 1 diabetes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 15, 2003
• Est. primary completion date: October 15, 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes

• Treatment with insulin for at least 6 months prior to inclusion

• HbA1c below or equal to 11.0 %

• Currently treated with short acting, intermediate acting, long acting human insulin or analogues or a self-mix of these insulins at least 1 month prior to inclusion

Exclusion Criteria:

• The receipt of any investigational drug within one month prior to this trial

• Recurrent severe hypoglycaemia or hypoglycaemic awareness as judged by the investigator

• Total daily insulin doses at least 1.80 IU/kg

• Treatment with oral hypoglycaemic agents

• Known or suspected allergy to trial product or related products

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 1

Intervention

Drug:
• insulin aspart
Injected s.c. (under the skin) three times a day
• human insulin
Injected s.c. (under the skin) 30 minutes before the meals
• isophane human insulin
May be administered s.c. (under the skin) in both treatment groups thrice daily

Locations

Country	Name	City	State
Germany	Novo Nordisk Investigational Site	Berlin
Germany	Novo Nordisk Investigational Site	Dresden
Germany	Novo Nordisk Investigational Site	Hagen
Germany	Novo Nordisk Investigational Site	Hamburg
Germany	Novo Nordisk Investigational Site	Hannover
Germany	Novo Nordisk Investigational Site	Osnabrück

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Danne T, Råstam J, Odendahl R, Näke A, Schimmel U, Szczepanski R, Moeller J, Deiss D. Parental preference of prandial insulin aspart compared with preprandial human insulin in a basal-bolus scheme with NPH insulin in a 12-wk crossover study of preschool c — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of hypoglycaemic episodes during the treatment		Week 0; week 24
Primary	Change in HbA1c (glycosylated haemoglobin A1c)		Week 0; week 24
Secondary	Incidence of Adverse Events (AEs)		Week 0; week 24

External Links

•   Clinical Trials at Novo Nordisk